InClin, Inc

QA Engineer

• Write, revise, and review SOPs, policies, working practices, investigation reports, and quality metric trend reports
• Perform audits and maintain Annual Audit Plans for internal departments, CROs, specialty service providers, and clinical studies
• Co-host FDA and regulatory inspections
• Manage the company-wide electronic Quality Management System (eQMS) for Document Control, Training, Deviations, Complaints, and CAPAs
• Oversee Computer System Validation (CSV) and Change Control Management
• Review non-conformance situations, evaluate root causes and corrective actions, and ensure timely closure
• Act as the designated QA Representative on clinical studies for Protocol Deviation Reviews and Risk Management
• Develop quality indicators and metrics to monitor system effectiveness
• Deliver GCP training sessions for internal and contract personnel

Quality Assurance Manager – Clinical